Solea

Laser, Dental, Soft Tissue

Convergent Dental, Inc.

The following data is part of a premarket notification filed by Convergent Dental, Inc. with the FDA for Solea.

Pre-market Notification Details

• Device ID: K221761
• 510k Number: K221761
• Device Name: Solea
• Classification: Laser, Dental, Soft Tissue
• Applicant: Convergent Dental, Inc. 140 Kendrick Street Needham, MA 02494
• Contact: Jhung Vojir
• Correspondent: Jhung Vojir; Convergent Dental, Inc. 140 Kendrick Street Needham, MA 02494
• Product Code: NVK
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-06-17
• Decision Date: 2022-09-14